The motion for preliminary injunction, Adheris, Inc. v Kathleen Sebelius et al, was filed in the U.S. District Court for the District of Columbia and seeks relief from the new regulations set to take effect Sept. 23.
One part of the final rule, according to HHS, aims to strengthen the privacy and security protection of individuals’ health information by limiting the use and disclosure of protected health information for marketing and fundraising purposes, and prohibit the sale of protected health information without individual authorization.
As to how Adheris is concerned, pharmaceutical companies currently pay pharmacies to send prescription refill reminders to patients and the pharmaceutical companies pay Adheris, which has contracts with 38 pharmacy chains, to send the reminders.
Adheris “collects the funds as agent for the pharmacies and facilitates disbursement to reimburse contracted pharmacies for reasonable costs,” Sydney Rubin, chief communications officer at inVentiv, told Outsourcing-Pharma.com.
“Adheris retains a portion for its services, as allowed under Adheris’ contracts with the pharmacies. Among the services offered by Adheris are content development, medical-regulatory review, performance measurement and reporting, program set up and management.”
Adheris does not sell the patient information to other companies and all letters “sent to patients clearly indicate the sponsor of the letter and provide easy instructions for simple opt-out of receiving future mail,” Rubin added.
Since 1993 Adheris “has sent hundreds of millions of communications to patients and handled billions of prescription records without ever having a security breach. Not only is data not sold, it is not shared in any way with any entity,” she said.
In its motion Adheris argues that its speech is protected as communications to patients by the First Amendment's role in furthering the "free flow of information." The US Supreme Court recently ruled in Sorrell v IMS Health, Inc. that "speech in aid of pharmaceutical marketing… is a form of expression protected by the Free Speech Clause of the First Amendment."
In addition, the company points out that the rule “contradicts other parts of HHS – including CMS and AHRQ – which encourage and promote refill reminder programs,” Rubin told us.
If the rule goes through, Adheris would find itself in serious financial straits. According to the motion, Adheris in 2012 “derived total revenues of $49 million from its refill reminder and adherence message services, which together account for more than 90% of Adheris’s total revenues.”
And in terms of the effectiveness of the reminders in helping patients stick to their drug regimens, Adheris admits in the motion that controlled and randomized tests on the effectiveness of its programs “have found that patients in its programs are 2 to 7 percent more likely to be on their therapy at the end of the program period.”
inVentiv is now “awaiting a date to be set for the hearing on our Preliminary Injunction and are hopeful that the court will agree with our position that our reminders are highly useful to patients, an extension of treatment and protected by the First Amendment,” Rubin added.